10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MEDTECH C.P.R. MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Avalon Fetal Monitor FM30
FDA UDI
Philips Medizin Systeme Böblingen GmbH·00884838000414·Avalon FM30 Fetal Monitor for all external and ...
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Cascade IOMAX Intraoperative Monitor
FDA 510(k)
FDA Class 2
·Neurology
ENDOSCOPE 5.5MM
FDA Adverse Event
Injury
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code GCJ·December 5, 2020
CAPSURE
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 7, 2012
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 17, 2015
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012